Manager, Manufacturing Science & Technology
Amneal Pharmaceuticals
August 20, 2026
On-site
Brookhaven, NY
Operations
Essential Functions:
- Provide technical support for sterile operations (BFS, prefilled syringes, bag filling, formulation, filtration, aseptic transfers, filling setup, container closure, visual inspection).
- Lead or support validation lifecycle activities (PPQ, CPV, monitoring, trending); manage tech transfer, scale up, site transfer, new product introduction, and lifecycle management.
- Serve as MS&T SME for deviations/nonconformances, OOTs, failures, yield losses, contamination events; lead investigations, impact assessments, CAPAs, and batch disposition support.
- Establish/improve control strategies (CPPs, CQAs, IPCs, parameters, criteria); support contamination control, APS, EM trending, cleanroom controls, and sterile assurance investigations.
- Partner with Engineering, Manufacturing, Validation, QA, and Automation on equipment qualification, process improvements, facility upgrades, and manufacturing readiness; lead/support change control assessments.
- Author/review technical documents (protocols, reports, SOPs, risk assessments, CPV, investigations); support audits/regulatory inspections; provide technical coaching to junior staff.
Qualifications:
- Education: Bachelor’s degree (BA/BS) in Pharmaceutical Sciences, Pharmacy, Chemical/Mechanical/Biomedical Engineering, Microbiology/Biology/Chemistry/Biotechnology/Life Sciences, or related field (Required).
- Experience: 5+ years in pharmaceutical manufacturing/MS&T/technical services/process engineering/validation/process development/sterile operations (or technical operations); 3+ years in sterile manufacturing and BFS/prefilled syringes/sterile bag filling/sterile filtration/vial/cartridge filling/formulation/aseptic filling; 5+ years with PPQ/CPV/process characterization/technology transfer/continued process monitoring; 3+ years supporting FDA/EMA/customer/internal audits and using statistical process control tools (Minitab, JMP, or similar).
- Specialized Knowledge/Skills: Strong sterile/aseptic technical judgment; troubleshooting; technical writing, data analysis, and investigation skills; cross-functional leadership/influence; communication with Manufacturing/QA/QC/Engineering/Validation/Regulatory/Supply Chain; manage multiple priorities in a GMP environment; high documentation quality and compliance/audit readiness; floor-oriented problem-solving.
- Additional Requirement: Successful completion of an OSHA-compliant Respirator Fit Test.
Application instructions/compensation:
- Base salary range: $145,000–$160,000 per year.
- Provide technical support for sterile operations (BFS, prefilled syringes, bag filling, formulation, filtration, aseptic transfers, filling setup, container closure, visual inspection).
- Lead or support validation lifecycle activities (PPQ, CPV, monitoring, trending); manage tech transfer, scale up, site transfer, new product introduction, and lifecycle management.
- Serve as MS&T SME for deviations/nonconformances, OOTs, failures, yield losses, contamination events; lead investigations, impact assessments, CAPAs, and batch disposition support.
- Establish/improve control strategies (CPPs, CQAs, IPCs, parameters, criteria); support contamination control, APS, EM trending, cleanroom controls, and sterile assurance investigations.
- Partner with Engineering, Manufacturing, Validation, QA, and Automation on equipment qualification, process improvements, facility upgrades, and manufacturing readiness; lead/support change control assessments.
- Author/review technical documents (protocols, reports, SOPs, risk assessments, CPV, investigations); support audits/regulatory inspections; provide technical coaching to junior staff.
Qualifications:
- Education: Bachelor’s degree (BA/BS) in Pharmaceutical Sciences, Pharmacy, Chemical/Mechanical/Biomedical Engineering, Microbiology/Biology/Chemistry/Biotechnology/Life Sciences, or related field (Required).
- Experience: 5+ years in pharmaceutical manufacturing/MS&T/technical services/process engineering/validation/process development/sterile operations (or technical operations); 3+ years in sterile manufacturing and BFS/prefilled syringes/sterile bag filling/sterile filtration/vial/cartridge filling/formulation/aseptic filling; 5+ years with PPQ/CPV/process characterization/technology transfer/continued process monitoring; 3+ years supporting FDA/EMA/customer/internal audits and using statistical process control tools (Minitab, JMP, or similar).
- Specialized Knowledge/Skills: Strong sterile/aseptic technical judgment; troubleshooting; technical writing, data analysis, and investigation skills; cross-functional leadership/influence; communication with Manufacturing/QA/QC/Engineering/Validation/Regulatory/Supply Chain; manage multiple priorities in a GMP environment; high documentation quality and compliance/audit readiness; floor-oriented problem-solving.
- Additional Requirement: Successful completion of an OSHA-compliant Respirator Fit Test.
Application instructions/compensation:
- Base salary range: $145,000–$160,000 per year.